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0ensitive Eyes(tm) Saline & Cleaning Solution

FDA PMA

Class II (US FDA PMA)

PMA P820031

by Bausch & Lomb, Inc.

Identity

Trade Name
SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION FDA PMA
Generic Name
Accessories, soft lens products FDA PMA

Identifiers

PMA Number
P820031 FDA PMA
FDA Product Code
LPN FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 886.5928 FDA PMA
Regulation Number
886.5928 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA
PMA Supplement
S006 FDA PMA

This device is classified as Accessories, Soft Lens Products under the nomenclature authority’s definition, serving as a sterile ophthalmic solution designed for cleaning and rinsing soft contact lenses. It provides a balanced saline formulation to maintain lens hygiene and comfort while minimizing irritation or damage to the lens material.

The solution is supplied as a single-use, sterile ophthalmic product intended for use in home or clinical settings. It is packaged in individual containers and must be stored at room temperature, protected from light and contamination. Authorized under an FDA Premarket Approval (PMA), this device adheres to regulatory standards for ophthalmic accessories, ensuring compatibility with soft contact lens care routines.

Frequently asked questions

Is this solution reusable or intended for single-use only, and how should it be stored?

This solution is designed for single-use only per its packaging and labeling. Each container is meant for one-time use to maintain sterility and hygiene. Storage instructions specify keeping it at room temperature, protected from light and contamination to preserve its effectiveness and prevent degradation.

What types of contact lenses is this solution compatible with, and why?

This solution is specifically formulated for soft contact lenses only, as indicated by its classification under *Accessories, Soft Lens Products*. Its balanced saline formulation is designed to maintain lens hygiene and comfort without causing irritation or damage to soft lens materials, which are more delicate than rigid gas-permeable lenses.

How is the regulatory approval process for this device structured, and what does it mean for users?

This device holds an FDA Premarket Approval (PMA), which is the highest level of regulatory clearance for medical devices in the U.S. The PMA process ensures rigorous evaluation of safety and effectiveness before market authorization. For users, this means the solution has undergone thorough testing to confirm its compatibility with soft contact lens care routines and adherence to ophthalmic standards, providing confidence in its reliability for home or clinical use.

Are there different sizes or models of this solution, and if so, how do they differ?

The provided data does not specify variations in sizes or models beyond the core product—*SENSITIVE EYES™ SALINE & CLEANING SOLUTION*—which is supplied in individual, single-use containers. The focus is on its sterile ophthalmic formulation and compatibility with soft lenses, rather than differing volumes or formulations. If multi-pack or larger-volume options exist, they would not be reflected in the regulatory filings shared.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P820031 23 fields · synced Sep 18, 2026